FDA.reportPublic FDA data

Extended Phenytoin Sodium

Product NDC
72162-2514
11-digit product format
721622514
Labeler code
72162
Product ID
72162-2514_374e2998-0c04-c804-e063-6394a90a67c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204309
Marketing category
ANDA
Marketing start
2015-06-10
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extended Phenytoin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2514-0Extended Phenytoin Sodium1000 in 1 BOTTLECAPSULE1000100
72162-2514-1Extended Phenytoin Sodium100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2514-0EA - Each72162-2514501754f4-3e26-4d8b-9394-b601335e3bf112025-07-08
72162-2514-1EA - Each72162-2514e74eba36-4796-4c7b-aaf5-f919a4be34c712025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNa9a1059e-63a2-486e-aa50-eda388f79525100
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDa9a1059e-63a2-486e-aa50-eda388f79525100
855671DPH sodium 100 MG Extended Release Oral CapsuleSYa9a1059e-63a2-486e-aa50-eda388f79525100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2514-0721622514001000 CAPSULE in 1 BOTTLE (72162-2514-0) 1000 capsule2025-06-09NoNoCurrent
72162-2514-172162251401100 CAPSULE in 1 BOTTLE (72162-2514-1) 100 capsule2025-06-09NoNoCurrent